Intermittent catheters are generally catheters or tubes having a rounded tip connected to a distal end that is inserted into the bladder of a patient or user, and a molded funnel connected to a proximal end that remains outside the body of the patient or user. These types of catheters are typically utilized on a temporary basis to remove urine from the bladder of a patient or user. The distal tip may include slots or openings on the shaft to facilitate drainage of urine therefrom once the tip is positioned inside the bladder. Pre-wetted intermittent catheters are intermittent catheters having a highly lubricious coating on an outer surface thereof, which are packaged or otherwise brought into contact with fluid in order to provide a catheter with a slippery outer surface to facilitate insertion into the patient or user.
Intermittent catheters are well-known in the art, and include those disclosed in U.S. Pat. Nos. 5,895,374; 6,059,107; 6,634,498; 7,311,698; 6,849,070, 7,615,045; 6,736,805; 7,087,048; 7,380,658; and 6,355,004, the disclosures of which are all incorporated herein by reference in their entirety as if fully set forth herein.
The current offerings of pre-wetted intermittent catheters can be broken up into three broad categories. In the first type, the catheter is packaged in a dry environment, but contains a lubricious coating that requires a wetting fluid in order to become hydrated. The wetting fluid is obtained from an external source by the user (e.g., sink, bottled water, etc.) and the catheter is positioned within the wetting fluid for a period of time to become hydrated. Use of this first type of intermittent catheter may prove difficult in the event that drainage must be performed by the user when no clean water or wetting fluid is available. Moreover, sterility of the catheter may be compromised due to the handling of the catheter by the user as wetting fluid is applied and thereafter during insertion.
A second type of pre-wetted intermittent catheter is also packaged in a dry environment and contains a lubricious coating. In this second type, the wetting fluid is positioned in a pouch or container within the catheter package itself such that to hydrate the catheter, the pouch or container must be opened when the user is ready for insertion. A third type of pre-wetted intermittent catheter is packaged in a wet environment (i.e., the catheter is exposed to a wetting fluid within the catheter package).
Intermittent catheterization is generally performed a minimum of three times a day by the patient or a care giver in order to drain the bladder. The genital area near the urethral opening is wiped with an antiseptic agent, such as iodine. A lubricant may then be used to facilitate the entry of the catheter into the urethra. A topical local anesthetic may also be applied to numb the urethral opening during the procedure. The catheter packaging is opened, and the catheter is removed. One end of the catheter is placed in a container, and the other end is inserted into and guided up the urethra and into the bladder until urine flow begins.
Some patients requiring intermittent catheterization may have limited dexterity resulting from, for example, traumatic brain or spinal cord injury, or a disease state (e.g., spina bifida, multiple schlerosis). Such patients may have difficulty opening the packaging of an intermittent catheter, and may further have difficulty during insertion. Fumbling with the catheter and/or its packaging is potentially harmful to the patient, because the sterile surfaces of the catheter may become non-sterile. Inserting a non-sterile urinary catheter increases the likelihood of contracting a urinary tract infection.
Packaging is a separate issue associated with intermittent urinary catheterization. It could be desirable to provide an intermittent urinary catheter in a discrete, compact packaged unit to improve the ease of use, convenience, and privacy of the intermittent catheterization process for the user.
Thus, there is a need for an intermittent catheter that addresses at least one of the needs of the patient or user, e.g., is easy to use, is quick, clean, compact, capable of use with or without a bag, and is capable of maintaining sterility during insertion procedures.